Device is latest example that wearable healthcare devices are moving past simple biomarker monitoring and into the area of assisting in rehab
Companies unrelated to traditional clinical laboratory medicine continue to develop wearable devices that enable individuals to monitor their health while also alerting physicians and caregivers in real time when certain biomarkers are out of range.
One recent example is US biotechnology company STAT Health Informatics in Boston, which has developed a wearable device that monitors blood flow to the ear and face “to better understand symptoms such as dizziness, brain fog, headaches, fainting, and fatigue that occur upon standing,” according to a press release. The tiny device is worn in the ear and connects wirelessly to a smartphone app.
Johns Hopkins University clinically tested the STAT device, and according to Medical Device Network, “It can predict a person fainting minutes before it happens and can be worn with more than 90% of devices that go in or around the ear. It can also be left in while sleeping and showering, meaning less likelihood of removing the device and forgetting to replace it.”
Another notable aspect of this invention is that it’s an example of how the ongoing miniaturization of various technologies makes it possible to invent smaller devices but with greater capabilities. In the case of the STAT device, it combines tiny sensors, Bluetooth, and an equally tiny battery to produce a device that fits in the ear and can function for up to three days before needing a recharge.
It’s easy to imagine these technologies being used for other types of diagnostic testing devices that could be managed by clinical laboratories.
“It’s well understood that the ear is a biometric gold mine because of its close proximity to the brain and major arteries. This allows for new biometrics … to be possible,” said Daniel Lee (above), co-founder and CEO of STAT Health, in a press release. “In addition, the ear is largely isolated from data corruption caused by arm motion—a problem that plagues current wearables and prevents them from monitoring heart metrics during many daily tasks. The ear is really the ideal window into the brain and heart.” Clinical laboratory managers may want to watch how this technology is further developed to incorporate other biomarkers for diseases and health conditions. (Photo copyright: STAT Health.)
How STAT Works
Every time the wearer stands, the STAT device tracks the change in response of blood pressure, heart rate, and blood flow to the head. “The device distills all this information into an ‘Up Score’ to track time spent upright. Its ‘Flow Score’ helps users pace their recovery by watching for blood flow abnormalities,” MassDevice reported.
According to the company’s website, STAT is intended for use in individuals who have been diagnosed with conditions known to suffer from drops in blood flow to the head, such as:
As an individual continues to use the device, STAT “learns about each user’s unique body to provide personalized coaching for healthy lifestyle choices,” MassDevice reported.
Another key factor is the technology built into the device. An optical sensor was chosen over ultrasound because STAT Health felt it was both easy to use and provided precise measurements accessing the shallow ear artery, MassDevice reported.
“Despite its small scale, the device incorporates advanced optical sensors, an accelerometer, a pressure sensor, temperature sensors, artificial intelligence (AI)-edge computing, three-day battery life (or more), and a micro solar panel,” Medical Device Network noted.
STAT’s image above demonstrates how truly minute the company’s wearable device is, even though it monitors blood flow to the face and ear looking for signs that the wearer is about to suffer bouts of dizziness or lightheadedness due to a drop in blood flow. (Photo copyright: STAT Health Informatics Inc.)
STAT’s Impact on Users’ Health
STAT’s developers intend the device to help individuals stay on track with their health. “The target population can navigate their condition better. If they’re not standing when they can, they will become deconditioned. This product encourages standing and being upright where possible, as part of rehab,” Lee told Medical Device Network.
Lee has been developing wearable in-ear devices for many years.
“Nobody has realized the ear’s true potential due to the miniaturization and complex systems design needed to make a practical and user-friendly ear wearable,” he told MassDevice. “After multiple engineering breakthroughs, we’ve succeeded in unlocking the ear to combine the convenience and long-term nature of wearables with the high fidelity nature of obtrusive clinical monitors. No other device comes close along the axis of wearability and cardiac signal quality, which is why we believe STAT is truly the world’s most advanced wearable.”
For clinical laboratories, though STAT is not a diagnostic test, it is the latest example of how companies are developing wearable monitoring devices intended to allow individuals to monitor their health. It moves beyond the simple monitoring of Apple Watch and Fitbit. This device can aid individuals during rehab.
Wearable healthcare devices will continue to be introduced that are smaller, allow more precise measurements of target biomarkers, and alert wearers in real time when those markers are out of range. Keeping in tune with the newest developments will help clinical laboratories and pathologists find new ways to support healthcare providers who recommend these devices for monitoring their patients conditions.
Spectroscopic technique was 91% accurate in identifying the notoriously difficult-to-diagnose disease suggesting a clinical diagnostic test for CFS may be possible
Most clinical pathologists know that, despite their best efforts, scientists have failed to come up with a reliable clinical laboratory blood test for diagnosing myalgic encephalomyelitis (ME), the condition commonly known as chronic fatigue syndrome (CFS)—at least not one that’s ready for clinical use.
But now an international team of researchers at the University of Oxford has developed an experimental non-invasive test for CFS using a simple blood draw, artificial intelligence (AI), and a spectroscopic technique known as Raman spectroscopy.
The approach uses a laser to identify unique cellular “fingerprints” associated with the disease, according to an Oxford news release.
“When Raman was added to a panel of potentially diagnostic outputs, we improved the ability of the model to identify the ME/CFS patients and controls,” Karl Morten, PhD, Director of Graduate Studies and Principal Investigator at Oxford University, told Advanced Science News. Morton led the research team along with Wei Huang, PhD, Professor of Biological Engineering at Oxford.
The researchers claim the test is 91% accurate in differentiating between healthy people, disease controls, and ME/CFS patients, and 84% accurate in differentiating between mild, moderate, and severe cases, the new release states.
“This could be a game changer as we are unsure what causes [ME/CFS] and diagnosis occurs perhaps 10 to 20 years after the condition has started to develop,” said Karl Morten, PhD, Director of Graduate Studies and Principal Investigator at Oxford University. “An early diagnosis might allow us to identify what is going wrong with the potential to fix it before the more long-term degenerative changes are observed.” Though this research may not lead to a simple clinical laboratory blood test for CFS, any non-invasive diagnostic test would enable doctors to help many people. (Photo copyright: Oxford University.)
Need for an ME/CFS Test
The federal Centers for Disease Control and Prevention (CDC) describes ME/CFS as “a serious, long-term illness that affects many body systems,” with symptoms that include severe fatigue and sleep difficulties. Citing an Institute of Medicine (IoM) report, the agency estimates that 836,000 to 2.5 million Americans suffer from the condition but notes that most cases have not been diagnosed.
“One of the difficulties is the complexity of the disease,” said Jonas Bergquist, MD, PhD, Director of the ME/CFS Research Center of Uppsala University in Sweden, told Advanced Science News. “Because it’s a multi-organ disorder, you get symptoms from many different regions of the body with different onsets, though it’s common with post viral syndrome to have different overlapping [symptoms] that disguise the diagnosis.” Bergquist was not involved with the Oxford study.
One key to the Oxford researchers’ technique is the use of multiple artificial intelligence models to analyze the spectral profiles. “These signatures are complex and by eye there are not necessarily clear features that separate ME/CFS patients from other groups,” Morten told Advanced Science News.
“The AI looks at this data and attempts to find features which can separate the groups,” he continued. “Different AI methods find different features in the data. Individually, each method is not that successful at assigning an unknown sample to the correct group. However, when we combine the different methods, we produce a model which can assign the subjects to the different groups very accurately.”
Without a reliable test, “diagnosis of the condition is difficult, with most patients relying on self-report, questionnaires, and subjective measures to receive a diagnosis,” the Oxford press release noted.
But developing such a test has been challenging, Advanced Science News noted.
How Oxford’s Raman Technique Works
Raman spectroscopy uses a laser to determine the “vibrational modes of molecules,” according to the Oxford press release.
“When a laser beam is directed at a cell, some of the scattered photons undergo frequency shifts due to energy exchanges with the cell’s molecular components,” the press release stated. “Raman micro-spectroscopy detects these shifted photons, providing a non-invasive method for single cell analysis. The resulting single cell Raman spectra serve as a unique fingerprint, revealing the intrinsic and biochemical properties and indicating the physiological and metabolic state of the cell.”
The researchers employed the technique on blood samples from 98 subjects, including 61 ME/CFS patients, 16 healthy controls, and 21 controls with multiple sclerosis (MS), Advanced Science reported.
The Oxford scientists focused their attention on peripheral blood mononuclear cells (PBMCs), as previous studies found that these cells showed “reduced energetic function” in ME/CFS patients. “With this evidence, the team proposed that single-cell analysis of PBMCs might reveal differences in the structure and morphology in ME/CFS patients compared to healthy controls and other disease groups such as multiple sclerosis,” the press release states.
Clinical Laboratory Blood Processing and the Oxford Raman Technique
Oxford’s Raman spectroscopic technique “only requires a small blood sample which could be developed as a point-of-care test perhaps from one drop of blood,” the researchers wrote. However, Advanced Science News pointed out that required laser microscopy equipment costs more than $250,000.
In their Advanced Science paper, the researchers note that the test could be made more widely available by transferring blood samples collected by local clinical laboratories to diagnostic centers that have the needed hardware.
“Alternatively, a compact system containing portable Raman instruments could be developed, which would be much cheaper than a standard Raman microscope, and [which] incorporated with microfluidic systems to stream cells through a Raman laser for detection, eliminating the need for lengthy blood sample processing,” the researchers wrote.
They noted that the technique could be adapted to test for other chronic conditions as well, such as MS, fibromyalgia, Lyme disease, and long COVID.
“Our paper is very much a starting point for future research,” Morten told Advanced Science News. “Larger cohorts need to be studied, and if Raman proves useful, we need to think carefully about how a test might be developed.”
Bergquist agreed, stating it’s “not necessarily something you would see in a doctor’s office. It requires a lot of advanced data analysis to use—I still see it as a research methodology. But in the long run, it could be developed into a tool that could be used in a more simplistic way.”
Though a useable diagnostic test may be far off, clinical laboratories should consider how they can aid in ME/CFS research.